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Completed

NCT Number: NCT03265704

Maternal High Blood Pressure and Newborn's Blood Profile

Maternal high blood pressure remodels the intrauterine environment of the fetus by altering hormonal and cellular signaling patterns and, as a result increases the risk of fetal and neonatal mortality and morbidity. Newborns of these mothers have an increased risk of intrauterine growth restriction, premature birth and hematological abnormalities, such as thrombocytopenia, polycythemia, and neutropenia. The purpose of the article is to review neonatal thrombocytopenia and neutropenia as a consequence of maternal high blood pressure and to establish the optimal management of these cases.

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Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Romanian Society of Anesthesia and Intensive Care

Timișoara, Romania

About this study

Pregnancy induced hypertension (PIH) and preeclampsia (preE) are caused by gestation and have an onset after 20 weeks of pregnancy. Although the exact etiology of PIH and preE remains unknown, two interconnected mechanisms have been identified to play an important role in the pathogenesis: dysfunction of the placental trophoblast and endothelial dysfunction within the maternal systemic vasculature. The endothelium has been identified as the target tissue of the disease. Endothelial alterations ultimately manifest as placental hypoxia and hypoplasia. The neonatal thrombocytopenia and neutropenia after pregnancy-induced hypertension is a result of inhibition of fetal bone marrow production of the myeloid lineage due to intrauterine hypoxic environment. This study aims to investigate the hematological profile in term and preterm infants born to mothers with preeclampsia. The current retrospective observational study was conducted at the Clinic of Obstetrics, Gynecology and Neonatology of the Emergency County Hospital, Timisoara over a period of three years, from January 2014 to December 2016. All inborn patient files were analyzed as anonymised limited data sets from archived records of the Neonatology Department.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 0-28 days
  • Newborns of healthy mothers;
  • Newborns of mothers with Pregnancy Induced Hypertension;
  • Inborn Patients;
  • Written Informed Consent signed by legal guardian.

Exclusion criteria

  • Maternal disease other than PIH;
  • Syndromal, chromosomal or infectious diseases of the newborns;
  • Causes other then PIH for perinatal asphyxia.

Treatment and study plan

AGA - Control group

Other

Data processing from Patient Medical Files

SGA - Control group

Other

Data processing from Patient Medical Files

AGA-PIH Study group

Other

Monitoring PIH-related changes in the newborn

SGA-PIH Study group

Other

Monitoring PIH-related changes in the newborn

Primary outcomes

  1. Hematological Changes in the Newborns of Mothers with Pregnancy Induced Hypertension

    Time frame: Blood profiles of newborns aged between 1-28 days were evaluated.

    Evaluating the impact of Maternal Pregnancy Induced Hypertension on fetal and neonatal hematopoiesis with focus on the myeloid lineage.

Sponsors and collaborators

Lead sponsor

Romanian Society of Anesthesia and Intensive Care

Other

Collaborators

  • Timişoara County Emergency Clinical Hospital
  • University of Medicine and Pharmacy "Victor Babes" Timisoara

Registry information

Official study title

Maternal Pregnancy Induced Hypertension and Hematological Profile of Newborns

Acronym: MPIHHPN

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 29, 2017
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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